COMPARISON OF REQUIREMENTS REQUESTED FOR POST-REGISTRATION CHANGES FOR DRUGS PRODUCED BY CHEMICAL SYNTHESIS IN CENTRAL AMERICAN AND CARIBBEAN COUNTRIES
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| Авторы: | , , , |
|---|---|
| Формат: | artículo original |
| Статус: | Versión publicada |
| Дата публикации: | 2026 |
| Описание: | The marketing authorization of medicines goods allows their commercialization in a specific nation. In addition, they have a dynamic life cycle, promoting previously approved modifications to the process or product. Such variations are known as post-approval changes. Because each country has regulations, the objective was to compare said changes and the associated requirements to modify the current marketing authorizations of drugs produced by chemical synthesis for human use in Central America, Jamaica, the Dominican Republic, and Trinidad and Tobago. For this, a review of regulations, standards, resolutions, and laws related to registering formulations produced by chemical synthesis for human use was done, precisely the requirements to make such modifications. Next, aspects shared by the nations of interest were compared, and differences in the requirements were established. The results showed 27 possible variations to the marketing authorization for Central America, while in Panama, the Dominican Republic, Jamaica, and Trinidad and Tobago, there are 31, 26, 23, and 9, respectively. It was proven that Central America has the most complete document regarding the number of changes and their respective requirements. As a complement, the various regulations associated with modifying the marketing authorization of drugs produced by chemical synthesis for human use in the countries of interest did not have harmonized variations and requirements. |
| Страна: | Portal de Revistas UCR |
| Институт: | Universidad de Costa Rica |
| Repositorio: | Portal de Revistas UCR |
| Язык: | Español |
| OAI Identifier: | oai:portal.revistas.ucr.ac.cr:article/3893 |
| Online-ссылка: | https://revistas.ucr.ac.cr/index.php/rmedica/article/view/3893 |
| Ключевое слово: | Medicamento, legislación, registro de medicamentos, América Central, Caribe. medicamento, legislación, registro de medicamentos, América Central, Caribe Pharmaceutical preparation, legislation, products registration, Central America, Caribbean region. |